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OpenTrials
Completed

NCT Number: NCT01540539

Intravenous/Subcutaneous FIH Study of REGN1154 in Healthy Volunteers

The purpose of this study is to study the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of REGN1154 in normal healthy subjects.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Melbourne, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile
  • Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive
  • Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures
  • Able to read or to understand the consent process, and willing to sign the informed consent form (ICF)

Exclusion criteria

Exclusion criteria

include, but are not limited to the following:

  • Any illness or condition that would adversely affect the subject's participation in this study
  • Any clinically significant abnormalities observed during the screening visit
  • Use of certain medications taken before the screening visit
  • Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit
  • Hospitalization within 60 days of the screening visit
  • Any condition that would place the subject at risk, interfere with participation in the study
  • History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
  • History of certain other conditions
  • Positive urine, drug or alcohol screen result at screening
  • Known sensitivity to any of the components of the investigational product formulation
  • Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit
  • Live/attenuated vaccinations within 12 weeks of screening or during the study

Treatment and study plan

REGN1154 or placebo

Drug

Participants will receive active drug or placebo

Primary outcomes

  1. Total number and severity of TEAEs

    Time frame: Day 1 through Day 113

    TEAEs (Treatment-emergent adverse events)

Secondary outcomes

  1. Serum concentration

    Time frame: Day 1 through Day 113

    Serum concentrations of REGN1154 over time

  2. Presence or absence of antibodies

    Time frame: Day 1 through Day 113

    Presence or absence of antibodies against REGN1154 over time.

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 28, 2012
Registry last updated
Jan 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.